Hydroxypropyldimethicone

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Overview

What Is It?

Dimethicone, also known as polydimethylsiloxane, is a silicon-based polymer that is a man-made synthetic molecule made up of repeating units called monomers. Silicon is the second most abundant element in the Earth's crust after oxygen, and silicon dioxide is also known as sand, commonly found on beaches and shores. Dimethicone can also be found in many cooking oils, processed foods and in fast food items such as chicken nuggets and French fries.

Why is it used in cosmetics and personal care products?

Dimethicone is used in the formulation of a wide range of cosmetics and personal care products including creams and lotions, bath soaps, shampoo and hair care products, where it functions primarily as an:

Scientific experts and authorities around the world have extensively reviewed dimethicone and found it safe for use in cosmetics applications. See below for more information on specific applications of dimethicone in personal care products that have approval from various regulatory authorities.

In 2003, the U.S. Cosmetic Ingredient Review (CIR) Expert Panel reviewed the safety data for dimethicone as well as a group of closely related silicon polymers that function primarily as skin and hair conditioning agents in cosmetics and personal care products and concluded that dimethicone is safe as currently used. The CIR Expert Panel, is an independent, non-profit scientific body that was initiated by the Personal Care Products Council (the Council) at the suggestion and with the support of the Food and Drug Administration (FDA) and the Consumer Federation of America (CFA) to assess the safety of ingredients used in cosmetics in the U.S. The CIR Expert Panel consists of world-renowned scientists and physicians who have been publicly nominated by consumer, scientific and medical groups, government agencies, and industry. The CIR and its review process are independent from the Council and the cosmetics industry. Members of the Expert Panel must meet the same conflict of interest requirements regarding financial interests as special non-government advisory experts to FDA.

The Joint FAO/WHO Expert Committee on Food Additives has established an acceptable daily oral intake level for dimethylpolysiloxane (dimethicone) of 0 to 1.5 mg/kg body weight. The maximum level (1.5 mg/kg body weight) is 100-fold lower than the level that caused no harmful effects in laboratory studies. Read more here.

CIR Safety Review: The 2003, the CIR Expert Panel reviewed the group of silicon A naturally occurring or synthetic molecule made up of repeating units called monomers.">polymer derivatives (Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C30-45 Alkyl Dimethicone, C24-28 Alkyl Dimethicone, C30-45 Alkyl Methicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearoxy Dimethicone, Stearyl Methicone, Stearyl Dimethicone, Vinyl Dimethicone). The ingredients were reviewed together because they are similar in structure, composition and use. The CIR Expert Panel considered the scientific information available for all of the ingredients in their determination of their safety for use in cosmetics and personal care products.

The CIR Expert Panel considered it unlikely that any of the silicone polymers would be significantly absorbed into the skin due to the large molecular weight of these polymers. Specifically for dimethicone, human clinical and laboratory absorption studies reported that it was not absorbed following dermal exposure. Laboratory studies supported the safety of dimethicone following single or repeated oral, skin or inhalation exposures. Laboratory and human clinical studies showed that dimethicone was not irritating to the skin and did not cause allergic skin reactions (i.e., was not a skin sensitizer). It was also reported to be mild to minimally irritating to the eyes. In laboratory reproductive and developmental toxicity studies, no adverse findings were reported in dosed pregnant females or their offspring.

Dimethicone was also shown not to cause genetic mutations in multiple laboratory studies. In a couple of laboratory studies with mice where dimethicone was administered orally or on the skin for a lifetime, there was no evidence of increased tumor incidence (i.e., dimethicone was not carcinogenic).

Evaluating all of the scientific data, the CIR concluded that dimethicone and the other closely related silicon polymers are safe as currently used in cosmetics and personal care products.

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